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BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01202630
Recruitment Status : Suspended (The site is unable to recruit patients.)
First Posted : September 16, 2010
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.

Condition or disease Intervention/treatment Phase
Recurrent Clostridium Difficile Infection Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei Dietary Supplement: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Study Start Date : June 2010
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Probiotic
BIO-K+ CL1285
Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
Other Name: BIO-K+ CL 1285
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days


Outcome Measures

Primary Outcome Measures :
  1. Incidence of recurrent Clostridium difficile infection [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Duration of recurrent diarrhea episodes [ Time Frame: 60 days ]
  2. Presence of gastrointestinal symptoms [ Time Frame: 60 days ]
  3. Adverse events [ Time Frame: 60 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
  3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
  4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  5. Understand the nature and purpose of the study including potential risks and side effects
  6. Willing to comply with the requirements of the study

Exclusion Criteria:

  1. History of 2 or more clostridium difficile infections at any time prior to the current episode
  2. Presence of severe chronic and/or inflammatory condition
  3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
  4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
  5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
  6. Use of proton pump inhibitors
  7. Pregnant female or breastfeeding
  8. Eating disorder
  9. History of alcohol, drug, or medication abuse
  10. Daily consumption of probiotics, fermented milk, and/or yogurt
  11. Known allergies to any substance in the study product
  12. Participation in another study with any investigational product within 3 months of screening
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202630


Locations
United States, New York
Parker Jewish Institute
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Bio-K Plus International Inc.
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Cornelius J Foley, MD Parker Jewish for Health Care and Rehabilitation
More Information

Publications:
Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT01202630     History of Changes
Other Study ID Numbers: 09-SUS-05-BIK-02
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Bio-K Plus International Inc.:
Clostridium difficile
diarrhea

Additional relevant MeSH terms:
Infection
Communicable Diseases